Disorder Related to TransplantationPhase 2/3NCT02447705
Replacement of Lamivudine by Telbivudine to Improve Renal Function
A Phase 2/3 study testing telbivudine in people with Disorder Related to Transplantation and Virus Diseases, run by Chang Gung Memorial Hospital.
Trial summary
Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular filtration rate. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorder Related to Transplantation, Virus Diseases, Injury Due to Exposure to External Cause
- What is being tested?
- telbivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to 31 Jan 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sign inform consent
- Age is not less than 16 years old.
- Post liver transplantation patient for HBV-related indication.
- Chronic hepatitis B transplant patients who are treated by lamivudine for not less than 6 months.
- eGRF stage 2-4 patients (15<eGFR<90ml)
- Stable liver function, ALT not more than 2 folds of upper limit.
Who cannot join
- Acute rejection with increase CNI dose within a month.
- Pregnant or nursing.
About this study
Official title: Replacement of Lamivudine by Telbivudine to Improve Renal Function for Post-transplant Hepatitis B Patients - a Randomized Clinical Trial
Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular filtration rate. This study is to see whether renal function is improved when Lamivudine is replaced by telbivudine in liver transplantation patients.
Read the detailed description
Liver transplantation is the only effective treatment for the patients with liver failure. Hepatitis B-related liver cirrhosis is the major indication to have liver transplantation in Taiwan. After liver transplantation, prophylaxis of hepatitis B recurrence will be performed by anti-hepatitis B immunoglobulin and anti-viral agents. Currently, lamivudine is the drug the investigators choose to prevent HBV recurrence for many years because it is safe for long-term use. However, nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Recently, the studies on chronic hepatitis B patients showed improvement of glomerular filtration rate for those receiving telbivudine treatment. In this study, the investigators will include our post-transplant HBV patients who have stable liver function, receive lamivudine for prophylaxis of recurrent hepatitis B, and have renal dysfunction in stage II-IV. The patients will be randomized to receive telbivudine or lamivudine continuously at 1:1 ratio. Renal function will be examined at 6 months interval to determine whether renal function is improved. The achievement will determine whether telbivudine is better than lamivudine for the HBV patients with renal dysfunction.
- Conditions
- Disorder Related to Transplantation, Virus Diseases, Injury Due to Exposure to External Cause
- Being tested
- telbivudine
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telbivudineDrug
Also called sobivo
telbivudine replace Lamivudine
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine group | No intervention | continue Lamivudine |
| Telbivudine group | Experimental | Telbivudine replaces Lamivudine Receives: Drug: telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function measurement
Measure eGFR when the patients were enrolled, every 2 months and up to 12 months. The most important time point will be to compare eGRF at 6 month and 12 months after medication conversion to the beginning levels. Renal function is improved if eGRF is better after medication conversion.
Measured: every 2 months, up to 12 months
Secondary outcomes (1)
hepatitis B recurrence
Measure hepatitis B surface antigen every 6 months. If HBs AG appears, hepatitis B recurrence is diagnosed.
Measured: every 6 months, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJun 2013
- Primary completion31 Dec 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to TransplantationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447705
- Sponsor's protocol ID
- CGMH-IRB-101-3476A3
- Status last verified
- Mar 2013
- First submitted
- 3 Jun 2013
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee WC, Wu TH, Wang YC, Cheng CH, Lee CF, Wu TJ, Chou HS, Chan KM, Lee CS. Renal Function Improvement by Telbivudine in Liver Transplant Recipients with Chronic Kidney Disease. Biomed Res Int. 2017;2017:9324310. doi: 10.1155/2017/9324310. Epub 2017 Aug 13.
PubMed 28884132
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replacement of Lamivudine by Telbivudine to Improve Renal Function for Post-transplant Hepatitis B Patients - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02447705
- Acronym / sponsor ID
- CGMH-IRB-101-3476A3
- Conditions
- Disorder Related to Transplantation, Virus Diseases, Injury Due to Exposure to External Cause
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular filtration rate. This study is to see whether renal function is improved when Lamivudine is replaced by telbivudine in liver transplantation patients.
Detailed description
Liver transplantation is the only effective treatment for the patients with liver failure. Hepatitis B-related liver cirrhosis is the major indication to have liver transplantation in Taiwan. After liver transplantation, prophylaxis of hepatitis B recurrence will be performed by anti-hepatitis B immunoglobulin and anti-viral agents. Currently, lamivudine is the drug the investigators choose to prevent HBV recurrence for many years because it is safe for long-term use. However, nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Recently, the studies on chronic hepatitis B patients showed improvement of glomerular filtration rate for those receiving telbivudine treatment. In this study, the investigators will include our post-transplant HBV patients who have stable liver function, receive lamivudine for prophylaxis of recurrent hepatitis B, and have renal dysfunction in stage II-IV. The patients will be randomized to receive telbivudine or lamivudine continuously at 1:1 ratio. Renal function will be examined at 6 months interval to determine whether renal function is improved. The achievement will determine whether telbivudine is better than lamivudine for the HBV patients with renal dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine group | No intervention | –continue Lamivudine |
| Telbivudine group | Experimental | Drug: telbivudineTelbivudine replaces Lamivudine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Sign inform consent
- Age is not less than 16 years old.
- Post liver transplantation patient for HBV-related indication.
- Chronic hepatitis B transplant patients who are treated by lamivudine for not less than 6 months.
- eGRF stage 2-4 patients (15<eGFR<90ml)
Key exclusion criteria (2 listed)
- Acute rejection with increase CNI dose within a month.
- Pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telbivudineAlso: sobivotelbivudine replace Lamivudine | Drug | Telbivudine group |
Primary outcome
Renal function measurement
Time frame: every 2 months, up to 12 months
Measure eGFR when the patients were enrolled, every 2 months and up to 12 months. The most important time point will be to compare eGRF at 6 month and 12 months after medication conversion to the beginning levels. Renal function is improved if eGRF is better after medication conversion.
1 secondary outcome
hepatitis B recurrence
Time frame: every 6 months, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Derived from this study: PubMed 28884132Lee WC, Wu TH, Wang YC, Cheng CH, Lee CF, Wu TJ, Chou HS, Chan KM, Lee CS. Renal Function Improvement by Telbivudine in Liver Transplant Recipients with Chronic Kidney Disease. Biomed Res Int. 2017;2017:9324310. doi: 10.1155/2017/9324310. Epub 2017 Aug 13.
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Hepatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing telbivudine in people with Disorder Related to Transplantation and Virus Diseases, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function measurement (time frame: every 2 months, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.